In May 2017, the new European Medical Device Regulation (2017/745) was published. It has a 3 year transition period which ends in May 2020.
The change from the MDD to the MDR is a big change. This is not a matter of a comma here or there, it's much more than that.
These changes have an impact on which devices will be considered as medical devices, their classification, documentation and testing. They will also impact on the responsibilities of economic operators (manufacturers, authorized representatives, importers and distributors) etc.
For device developers and economic operators the changes are significant. For the Notified Bodies, the change in legislation has a major impact.
At the time of publication of this post, we are roughly 7 months before the end of the transition period of the MDR. We would like to give a status update on 4 topics:
- Notified Bodies
- Harmonized Standards
The official end of the transition period for the MDR is 26th of May 2020.
The European Commission has published an Infographic Timeline.
So far, no changes in transition period or other timelines have been published.
Currently, EUDAMED is a secure web-based portal, only available for competent authorities and the European Commission. It is a central database for market surveillance information which is aimed at enhancing the communication between different national competent authorities. It is not publically accessible.
However, under the MDR, the scope of EUDAMED will be broader.
It will hold information on economic operators, UDI and devices; Notified Bodies and certificates; vigilance, clinical investigations and market surveillance. Part of it will be open for public consultation.
In theory, at the end of the transition period in 2020, EUDAMED should be live and fed will all necessary information. This will be a very challenging task. The new EUDAMED is not yet ready. On the website of the European Commission, they expect EUDAMED to be ready by the start of 2020. That will leave a mere 5 months for entering all information. No further information regarding these deadlines has been released, but it will be important to monitor any changes.
As mentioned before, the MDR doesn't only increase the pressure on manufacturers of medical devices, it is also a huge burden ffor the Notified Bodies. It was expected that some of the Notified Bodies would not apply for accreditation under the MDR due to increased requirements. However, only 5 Notified Bodies have actually obtained their accreditation for the MDR (based on the Nando website):
- BSI UK (NB0086)
- DEKRA Germany (NB0124)
- IMQ Italy (NB0051)
- TUV Rheinland Germany (NB0197)
- TUV SUD Germany (NB0123)
Knowing that currently 57 Notified Bodies appear on the Nando list, we can only hope that the rest are close to the final stages of obtaining their accreditation. We would urge you to monitor the Nando website, keep close contact with your current Notified Body and also understand whether (assuming they will be accredited for MDR) they will still be able to certify your product.
Harmonized standards give presumption of conformity to the Essential Requirements of the MDD, however, so far there have not been any harmonized standards published for the MDR.
The MDR also provides for the publication of "Common Specification", providing additional requirements whenever the European Commission finds it necessary (e.g. in case there are no harmonized standards or when there are safety concerns for users). It is the task of the Medical Device Coordination Group (MDCG) to establish these Common Specifications. Again, it is not clear yet when we can expect the first CS to be published.
We will try to keep you as updated as possible but the situation remains fluid and with a great deal of work to be done. Our best advice is to maintain a watchful eye on developments.